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Inside BioPort

Lansing lab works to reshape image

March 2, 2004
Bioport Corp. in Lansing is the only FDA licensed manufacturer of the Anthrax vaccine in the world.

Lansing - The production line at BioPort Corp. moves swiftly these days, operating around the clock to manufacture the nation's entire supply of anthrax vaccine.

The Lansing-based company, which produces the nation's only federally licensed anthrax vaccine, won a $245 million contract earlier this year to continue making its product for the Department of Defense.

Each day, BioPort employees step inside the barbed-wire perimeter of the 5-year-old company's plant on Martin Luther King Boulevard. Since the anthrax scare of 2001, BioPort's staff has grown by 50 percent and its facilities have experienced millions of dollars in enhancements.

The company's 330 employees recently celebrated a feat many doubted they ever would accomplish - supplying vaccine to immunize 1 million U.S. troops.

"BioPort is, No. 1, focusing on its core product, which is the anthrax vaccine," Michael Zamiara, BioPort's chief financial officer, said Thursday during an interview at the company's manufacturing plant. "We are looking at ways which we can make the vaccine a stronger vaccine, a better vaccine, and continuing to look for ways that we can move into different markets."

In 2001, BioPort took center stage when an anthrax scare gripped the nation. Amid a storm of publicity, the company was caught in a time of transition.

Three years earlier, a group of investors purchased the Michigan Biologic Products Institute from the state, which at the time was the nation's sole producer of anthrax vaccine. The investors gave the 70-year-old laboratory the name BioPort as they continued renovating the plant's run-down facilities.

In 1970, the Food and Drug Administration approved anthrax vaccine that was produced in the state's laboratories. The lab produced vaccine to immunize troops for the first Gulf War.

"Our overall process itself hasn't changed," said Christopher Pugh, a 2000 MSU graduate who works on the manufacturing end of BioPort's plant. "We are still making it the same way they did before it was BioPort."

After a struggle to gain FDA approval for its renovated facility, BioPort gained the proper certification two years ago - permitting the company to begin producing the vaccine in full force.

With two years of manufacturing and distributing the vaccine under its belt, BioPort now is expanding its focus and considering new places to sell its vaccine.

BioPort's once-crippled plant announced this week it had reached an agreement with the Taiwanese government to supply vaccine for their troops. That announcement marked the first sale of the company's vaccine outside the U.S. government.

Executives are now negotiating with five other nations.

In the next ten years, BioPort executives hope to have three or four licensed products, likely in the realm of bioterrorism defense.

Today, BioPort pumps out enough anthrax vaccine to immunize the military against a bioterrorism attack. But the production line at BioPort didn't always move so smoothly.

Warning signs

Three years ago, BioPort executives warned Americans that anthrax soon would evolve into more than a hoax. And they were right.

Nine months before the terrorist attacks and the anthrax scare of 2001, Robert Myers, BioPort's chief scientific officer, told area business leaders that at least 17 dangerous groups and governments likely possessed anthrax.

Osama bin Laden and the governments of Iraq, North Korea, China and Iran were among the likely suspects.

Myers told the business leaders to consider what would happen if a terrorist unleashed a bag of the lethal disease above 80,000 fans at Spartan Stadium.

"You know the planes that circle the stadium with advertising banners waving behind?" Myers said during a presentation to the Lansing Economic Club on Jan. 18, 2001. "Suppose one of those planes is outfitted with a simple aerosol generation device that dispersed anthrax spores into the air."

Within minutes, he said, the entire crowd and much of Lansing could be exposed. Because anthrax is colorless, odorless and tasteless, most of those infected with the disease wouldn't even know immediately.

"You and the rest of the fans would leave the game without a clue and disperse across Michigan and elsewhere," he said.

In the next two or three days, people would begin having flu-like symptoms.

"After a day or two, you might begin to feel better, but then it hits. You can't breathe, your body fills with toxins, you have multiple-organ failure and, within hours, your family is making funeral arrangements.

"That's how quick you will die."

At the beginning of 2001, BioPort was a young company trying to convince the world of the potential dangers of an anthrax attack. By the end of that year, the disease killed five people and came in contact with hundreds of others.

Anthrax strikes

With the spotlight focused sharply on BioPort to meet the demands of a potential biological attack, the company was forced to deliver.

Immediately after the attacks, "anthrax was a household word, and BioPort was on the map," BioPort spokeswoman Kim Brennen Root said.

For the first time, the U.S. Postal Service learned how to detect anthrax in packages, and many Americans thought twice before checking their mailboxes. "If you think about how this happened, and how simple that was and what it did to us - it paralyzed our country," Zamiara said. "People were going to their mailboxes and they had a sample of Tide in there and they suddenly had hazmat groups coming from all over the place."

Ultimately, the attacks served as a wake-up call against the looming danger of anthrax and other biological weapons.

As the anthrax scare raged on, BioPort's employees were working to gain FDA approval for their newly renovated facilities.

BioPort's lack of an FDA-approved manufacturing plant quickly exposed the company to rumors and cynicism. Some questioned the safety and effectiveness of the vaccine. Others claimed that the facility had been mismanaged and failed to produce the vaccine for three years.

"It was an enormous learning curve for the government, for the media, for the scientific community and the people in the medical profession," said Root, an MSU graduate who joined BioPort in 2000 to lead the embattled company in fixing its image among mounting criticism.

BioPort was bombarded with requests from the media, which sought to give outsiders a closer view of the nation's anthrax-vaccine maker. At the climax of the anthrax crisis, Oct. 23, 2001, Myers and Bob Kramer, the president and chief operating officer of BioPort, testified before a U.S. Senate committee on the state of the anthrax vaccine.

During Kramer's testimony, he said the media's coverage of BioPort had been an "Olympics of misinformation." That night, he appeared on CNN's "Larry King Live".

"Well, I guess my thoughts and concerns, first and foremost, Larry, are for the people who may be exposed to anthrax," Kramer told Larry King. "We have seen over the last couple weeks that this is a very serious and potentially deadly disease.

"And right now, that is the only reason that we are in business at BioPort is to produce the only FDA-licensed vaccine to prevent anthrax."

Building a reputation

Two years ago, BioPort's renovated facility gained approval from the FDA, permitting it to proceed with plans to produce the vaccine. That March, a report by the Institute of Medicine, a nonprofit scientific organization, deemed BioPort's vaccine safe and effective.

"There still seemed to be this cloud hanging over this vaccine," Zamiara said. "You had some scientists and the medical community in general taking a step back and saying, 'I don't know much about that vaccine and there is a lot of smoke there - there must be something wrong.'

"When the Institute of Medicine report came out, that really put a lot of that to rest."

During the summer of 2002, Department of Defense and Department of Human Services officials announced they were reinstituting the mandatory use of anthrax vaccine for select service members.

On June 28, 2002, Deputy Secretary of Defense Paul Wolfowitz released a statement acknowledging the reinstitution of the military's program.

"Given the deadly events of last fall and what we know of the threat of anthrax as a bioweapon, we are taking the action to provide protection to those service members who are at greatest risk," he said.

BioPort's vaccine was used to immunize troops who fought in Iraq and others across the globe who were considered by military officials to be at risk. Of those who received the vaccine, at least 10 reported adverse affects, according to Department of Defense documents. The troops typically receive a six-shot regimen and yearly boosters.

About a year ago, six anonymous plaintiffs filed suit, claiming the vaccine was illegal. A U.S. District Court judge suspended the military's anthrax program on Dec. 22. The suit claimed that product is illegal because it was not specify labeled for "inhalation" anthrax.

Within three weeks, however, the suspension was lifted, despite pending litigation.

The company, sporting battle scars from the past about its product, was unfazed.

"Okay, another challenge," Zamiara said. "We'll deal with it."

The Future

These days, Root says, there is optimism at BioPort that "the story is changing." Even so, doubters persist.

The Internet poses a hotbed of conspiracy theories targeting BioPort and its product. Thousands of Web sites claim wrongdoing by BioPort's ownership, while others continue to criticize defense policies and the effectiveness of the vaccine.

Some question whether anthrax is as deadly as once thought.

Michael Rip, an assistant professor in James Madison College and the Department of Epidemiology with a focus on national security, said widespread contamination isn't plausible.

"People get concerned about a hypothetical threat that they have no control over," Rip said. He added that it is "ridiculous" to think anthrax would kill even nearly as many people as the flu or car crashes.

BioPort executives contend that it isn't so simple.

"You look at it and say, 'Geez, more people were killed by rattlesnake bites than anthrax over the past three years,'" Zamiara said. "Well, yeah, but now let's walk through what could possibly happen with anthrax.

"You can't smell it, you can't taste it and you really don't know you have it until it is too late."

Steve Eder is the State News projects reporter. He can be reached at ederstev@msu.edu.

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